Closure device with textured surface

ABSTRACT

A closure device closes an opening in a body cavity. The closure device includes a closure member that has an external, tissue-engaging surface formed with tissue engaging surface irregularities. An elongate member is disconnectably connected to the closure member.

BACKGROUND OF THE INVENTION

[0001] The present invention relates to closing openings in a vessel orother body cavity. More specifically, the present invention relates to aclosure device that quickly closes openings in body tissue by engagingthe adventitia closely adjacent the wall of the body cavity.

[0002] There are a wide variety of procedures which require gaininginternal access to blood vessels or other body cavities. Many suchprocedures also require the insertion of treatment devices into theblood vessel or body cavity. Many of these procedures utilize accessiblearteries as entry points for the treatment devices. For example, somesuch arteries include the femoral artery or subclavian artery. There arealso a wide variety of procedures which gain access to other bodycavities in a minimally invasive fashion.

[0003] One problem which must be addressed during these procedures ishow to seal or close the opening in the blood vessel or other bodycavity once the treatment procedure has been completed. Some priortechniques include simply applying pressure to the opening until itseals itself sufficiently that the pressure may be released. However,this technique often requires that pressure must be consistently appliedfor an undesirable amount of time after the procedure. Similarly, thistype of technique can require a patient's hospitalization to be extendeduntil the treating physician is certain that the closure is complete.

[0004] Other techniques have involved suturing the wall of the vessel orbody cavity itself. This has typically required the physician to peelback a rather large portion of the tissue surrounding the puncture inorder to gain sufficient access to the blood vessel or body cavity thatit may be sutured adequately. This can be an undesirably time consumingprocedure, and it can result in significant discomfort to the patient.

[0005] Still other techniques have involved the insertion of embolicmaterials adjacent the puncture. Of course, this carries with it its owndifficulties. For instances, it is desirable that the embolic materialnot be placed within a blood vessel or body cavity because this canresult in an embolus forming within the blood vessel or body cavity.Similarly, however, it is desirable that the embolic material not belocated to far proximal of the puncture because this can result in theblood vessel or body cavity bleeding into the interstitial spaceproximal of the opening in the blood vessel or body cavity, but distalto the embolic material.

[0006] Similarly, when entry is gained into the lumen of the bloodvessel by puncturing the blood vessel, the vessel may not have beenpunctured in a direction entirely orthogonal to the longitudinal axis ofthe blood vessel. Instead, the blood vessel may be punctured in a “sidestick” fashion in which case the puncture is made in an off-centerposition. In such punctures, it is difficult to locate the outer wall ofthe blood vessel as well.

SUMMARY OF THE INVENTION

[0007] A closure device closes an opening in a body cavity. The closuredevice includes a closure member that has an external, tissue-engagingsurface formed with tissue engaging surface irregularities. An elongatemember is disconnectably connected to the closure member.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008]FIG. 1 is a side view of a portion of a blood vessel with anopening therein.

[0009] FIGS. 2A-2C illustrate one embodiment of closing the opening inthe vessel shown in FIG. 1.

[0010]FIG. 3 illustrates another embodiment for delivering a closuredevice.

[0011] FIGS. 4A-4C illustrate another embodiment for closing the openingshown in FIG. 1.

[0012]FIG. 5 illustrates another embodiment of a closure device.

[0013] FIGS. 6A-6F illustrate the operation of the closure device shownin FIG. 5.

[0014]FIG. 7 illustrates a closure plug in accordance with oneembodiment of the present invention.

[0015] FIGS. 8A-8C illustrate the formation of another closure plug inaccordance with one embodiment of the present invention.

[0016]FIGS. 9A and 9B illustrate a closure operation using the closureplug shown in FIGS. 8A-8C.

[0017] FIGS. 10A-10D illustrate a closure device in accordance withanother embodiment of the present invention.

DETAILED DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENTS

[0018]FIG. 1 is a side view of a portion of a blood vessel 10. While thepresent invention can be used with substantially any body cavity, ablood vessel is described herein for exemplary purposes only. Bloodvessel 10 has a lumen 12 defined by a blood vessel wall 14. Blood vesselwall 14 is shown as having an opening 16 therein. Opening 16 can be anopening which was made, for example, in order to perform a treatmentprocedure during which access to lumen 12 is needed. FIG. 1 alsoillustrates an access tract or opening 20 which was made when opening 16was made in vessel 10.

[0019] Vessel wall 14 is formed of media having an endothelium innerlayer. The media is generally smooth muscular tissue. As is known, themedia is surrounded by adventitia 18 which includes fibrous collagen.

[0020]FIG. 1A illustrates a closure apparatus in accordance with oneembodiment of the present invention. FIG. 1A shows that closureapparatus 22 includes an elongate delivery member 24 and a closure plug26. Elongate member 24 is, illustratively, a catheter or wire having ahollow distal tip. Closure plug 26 is made of a plugging material, suchas collagen, or another suitable material, which has a proximal end 28and distal surface irregularities (or hooks) 30. Hooks 30 illustrativelycomprise annular rings or discrete hooks disposed about the exteriorsurface of closure plug 26. The hooks 30 can form a regular pattern orbe randomly located. Hooks 30 are illustratively oriented such that theyare atraumatic when traveling in one direction, such as the directionindicated by arrow 32, and such that they grasp or grip surfaces whichthey engage when traveling in the opposite direction. In one embodiment,the hooks 30 face proximally so they only grip when travelingproximally. In another embodiment, hooks 30 are oriented randomly andare covered or encapsulated when traveling distally and are exposed whenin a desired position or when moved proximally, so they only grip whentraveling proximally.

[0021] The proximal end 28 of plug 26 is illustratively disconnectablyconnected to the distal end of elongate member 24. In one illustrativeembodiment, proximal end 28 of plug 26 is frictionally engaged withinthe distal hollow opening in elongate member 24. In another embodiment,plug 26 is attached through a disconnectable adhesive to the distal endof elongate member 24. In yet another embodiment, an active actuationmechanism can be used to disconnect plug 26 from elongate member 24, ora frangible or other disconnectable connection can be used.

[0022] Plug 26 is illustratively formed of collagen or any othersuitable plugging, biocompatible or bioabsorable material. Similarly, itmay require rigidity, in some embodiments, during deployment. Therefore,if it is formed of collagen, it can illustratively be coated, using anysuitable coating technique, by a coating which imparts rigidity for aninitial 30-90 seconds, or so. However, after that time, the rigiditywill illustratively give way to allow fluid to swell plug 26. One suchcoating may be, for example, hydroxypropycelluouse, which is a watersoluble polymer with favorable biocompatabiltiy properties.

[0023] FIGS. 2A-2C illustrate the use of closure plug 26 in closingopening 16 in vessel 10. As shown in FIG. 2A, closure apparatus 22 isfirst inserted, in a distal direction shown by arrow 34, through accesstract 20. Because hooks or ridges 30 are atraumatic when traveling inthe distal direction shown by arrow 34, plug 26 and elongate member 24slide easily through tract 20. Once inside the lumen 12 of vessel 10,elongate member 24 is retracted in the proximal direction opposite thatof arrow 34. This is better illustrated in FIG. 2B.

[0024]FIG. 2B shows that hooks 30, when retracted in the proximaldirection shown by arrow 36, do not engage the relatively smooth mediawhich forms wall 14 of vessel 10. However, when hooks 30 encounteradventitia 18, they immediately become securely lodged in tract 20. Inthe embodiment shown, the hooks 30 become snagged and entangled inadventitia 18. However, other means of becoming securely lodged arecontemplated as well, such as frictionally engagement of the surfaceirregularity and not simply entanglement. Because adventitia 18 liesimmediately proximal of media 14, plug 26 becomes entangled, in place,immediately proximal of opening 16. This placement is highly desired.

[0025]FIG. 2C illustrates that elongate member 24 is further withdrawnin the proximal direction shown by arrow 36. However, because the hooks30 of plug 26 have become securely entangled in the strong fibrouscollagen in adventitia 18, the frictional engagement (or otherdisconectable engagement) between plug 26 and the distal end of elongatemember 24 comes loose, such that plug 26 is disengaged from elongatemember 24. This leaves plug 26 in place, where it became entangled, justproximal of opening 16 in media 14 of vessel 10. Elongate member 24 isthen simply withdrawn through tract 20.

[0026]FIG. 3 illustrates another embodiment for deploying plug 26.Instead of simply advancing elongate member 24 and plug 26 through tract20, as shown in FIG. 2A, elongate member 24 and plug 26 are advanceddistally into lumen 12 of vessel 10 through an introducer sheath, suchas sheath 40. Sheath 40 may be a sheath specially formed to be used withapparatus 22, or it can simply be the introducer sheath which was usedin performing the treatment which required the formation of access tract20. In any case, once plug 26 is in place within lumen 12, introducersheath 40 is withdrawn proximally and the operation is completed asshown with respect to FIGS. 2B-2C.

[0027] FIGS. 4A-4C illustrate yet another embodiment in which plug 26 isused to close opening 16 in vessel 10. In the embodiment shown in FIGS.4A-4C, instead of elongate member 24 being used to deploy plug 26, acore wire or other flexible wire or thread 42 is used. In thisembodiment, plug 26 is advanced to within lumen 12 of vessel 10 througha delivery catheter (or through an introducer) designated as item 44 inFIG. 4A or it is advanced using a separate pusher, such as a catheter,not shown. In any case, once plug 26 is inserted within lumen 12 ofvessel 10, the items used for delivering it, other than elongate wire42, are withdrawn proximally.

[0028]FIG. 4B shows that wire 42 is then withdrawn proximally in thedirection indicated by arrow 46. This causes proximal movement of plug26, through the opening 16 defined by media 14. This also causes hooksor ridges 30 to engage adventitia 18 and become entangled therein.

[0029] In one embodiment, wire 42 is connected to the distal end of plug26 by a frangible connection which can simply be broken when enoughforce is applied to the connection point. Therefore, as shown in FIG.4C, once plug 26 becomes entangled in adventitia 14, and proximallydirected force is applied to wire 42, the connection point between theproximal end of plug 26 and wire 42 is broken, leaving plug 26 in place.Again, plug 26 is placed just proximal of the media 14 which definesopening 16 in vessel 10. Wire 42 is then simply withdrawn proximallythrough tract 20.

[0030]FIG. 5 illustrates another embodiment of a closure apparatus 50 inaccordance with one embodiment of the present invention. Apparatus 50includes a delivery sheath 52, a closure sheath 54, and a wire array 56which is disposed on a cone shaped seal member 58. Elongate members 52and 54 illustratively extend proximally all the way to a proximal regionaccessible by a user. Wire array 56 includes a plurality of individualwires 60, each of which have a hook 62 on its distal end. The wires 60in wire array 56 extend proximally in either a wire bundle 70, or theyare connected to a single wire 70 which extends proximally. Hooks 62,like hooks or ridges 30 shown in the above Figures, are oriented suchthat, as they are advanced in the direction shown by arrow 64, they areatraumatic. However, when withdrawn in the opposite direction, they hookor snag some tissues. Hooks 62 can be formed of conventional hooks usedwith hook and loop fabric (one embodiment which is sold under the tradename VELCRO), or they can be other desired hooks as well.

[0031] FIGS. 6A-6F illustrate one embodiment in which apparatus 50 isused for closing opening 60 in vessel 10.

[0032]FIG. 6A shows vessel 10 with an introducer sheath 80 insertedthrough opening 16 in vessel 10. FIG. 6A also shows that delivery sheath52 has been advanced distally relative to wire array 56 such that thedistal end 82 of delivery sheath 52 is in engagement with hooks 62. Inthis position, delivery sheath 52 is advanced distally relative tointroducer sheath 80 until the distal tip of apparatus 50 is withinlumen 12 of vessel 10 as shown in FIG. 6A.

[0033]FIG. 6B shows apparatus 50 in the same position as that shown inFIG. 6A, except that introducer sheath 80 has been withdrawn proximally.It can be seen that the sides of opening 16, once introducer sheath 80is withdrawn, close in around delivery sheath 52.

[0034]FIG. 6C shows that, in a next step, apparatus 50 is withdrawnproximally. In one embodiment, wire 70 is simply withdrawn proximally.This causes hooks 62 to withdraw delivery sheath 52 and elongate member54 in the proximal direction as well. Hooks 62 readily pass through thegenerally smooth media tissue forming opening 16. However, once theyencounter adventitia 18, they become firmly entangled therein, as shownin FIG. 6C. The treating physician can easily tell that apparatus 50 isin this position because the resistance to further proximal movement ofwire 70 becomes significant.

[0035] Closure sheath 54 is than advanced proximally over wire 70, wirearray 56, and wires 60, in the direction shown by arrow 84. This causesflexible cone-shape seal 58, and wires 60, to collapse inwardly pullinghooks 62 together. FIG. 6D shows closure sheath 54 advanced all the wayproximally relative to wire 70, such that hooks 62 are pulled closelyadjacent to one another at the distal end of closure sheath 54. Seal 58is shown collapsed within closure sheath 52.

[0036] In one embodiment, the proximal end of closure sheath 54 isillustratively provided with a snap lock fitting. Therefore, whenclosure sheath 54 is advanced a sufficient distance distally such thathooks 62 are substantially closed and in the position shown in FIG. 6D,the snap lock engages so the user can readily tell this. Of course, anyother relative measurement device can be used to indicate that thesheath 54 is in the position shown in FIG. 6D as well.

[0037]FIG. 6E shows that a plurality of closure plugs 86 have beendelivered to the closure site. One embodiment of a plurality ofgenerally disc shaped closure plugs 86 is shown in FIG. 7. The discshaped plugs 86 are illustratively, arranged generally coaxially andhave a central lumen 88 defined therethrough. The plugs can be formed ofcollagen, absorbable gel, or any other material or substance suitablefor closing opening 16. FIG. 6E shows that plugs 86 are illustrativelymounted over closure sheath 54 and advanced distally thereover byadvancing a second delivery sheath 90. Sheath 90 has a distal end whichis sized to engage the most proximal of disc-shaped plugs 86. Thedisc-shaped plugs 86 are advanced through delivery sheath 52 byadvancing delivery sheath 90 over closure sheath 54. Plugs 86 areadvanced to the position shown in FIG. 6E, just proximal of opening 16.

[0038] Next, wire array 56 is removed. This is better illustrated withrespect to FIG. 6F. FIG. 6F shows that closure sheath 54 is advancedfurther distally until it deforms hooks 62 until they reside within thedistal end of closure sheath 54. Once in that position, wires 70 andclosure sheath 54 are withdrawn proximally, to the position shown inFIG. 6F relative to second delivery sheath 90. At anytime during thisprocess, and after delivery of plugs 86, the first delivery sheath 52can be withdrawn proximally.

[0039] Delivery sheath 90 can then be used to tamp plugs 86 firmly inplace. Then, the entire system is withdrawn proximally, in any desiredorder.

[0040] FIGS. 8A-8C illustrate another embodiment of a plug 92 which canbe formed and used in accordance with the system shown in FIGS. 6A-6F.Plug 92 is formed of a sheet of material 94 having a generally centrallylocated aperture 96 therein. Sheet 94 can be substantially any shape,but is shown in a generally circular shape for the sake of simplicity.Sheet 94 is illustratively formed of a vascular occluding material suchas that in the QuickSeal Arterial Closure System from Sub-Q, Inc. of SanClamente, Calif. Sheets 94 are illustratively pliable material which canbe bent and folded. Therefore, sheets 94 are folded or twisted to afully collapsed shape having a generally central lumen extendingtherethrough, as shown in FIGS. 8B and 8C. Instead of loadingdisc-shaped plugs 86 over closure sheath 54, plugs 94 are loadedthereover.

[0041]FIGS. 9A and 9B illustrate delivery of a plug 94 using theapparatus shown in FIGS. 6A-6F. Plug 94 is advanced over closure sheath54 using sheath 90. Delivery sheath 52 is then withdrawn proximally, andclosure sheath 54 is advanced distally to retrieve hooks 62. Then,closure sheath 54 is withdrawn proximally and sheath 90 is advanceddistally to tamp in place plug 94. This is shown in FIG. 9B. Of course,a plurality of plugs 94 can be loaded onto closure sheath 54 anddelivered by sheath 90, either one at a time, or multiple plugs at asingle time, as desired.

[0042] FIGS. 10A-10D illustrate another embodiment of a closure devicein accordance with the present invention. In FIG. 10A, delivery sheath52 is shown inserted within the lumen 12 of vessel 10. A small bolus ofinert gas, such as CO₂, is then injected into vessel 10 through sheath52 (which can be attached to a source of the inert gas). This forms adry field 100 of the inert gas within the lumen 12 of vessel 10. Distalpressure on vessel 10 may be used in order to better hold the gas bolus100 in place.

[0043]FIG. 10B shows that a delivery apparatus 102 is then insertedthrough sheath 52 into lumen 12 of vessel 10. Delivery apparatus 102includes an elongate delivery sheath 104 an elongate delivery member106, and liquid swellable plug or plugs 108. Plugs 108 are insertedthrough sheath 52 until swellable plugs 108 are within the lumen 12 andreside at the distal end of sheath 52. This can be ensured by proximalmarkings on sheaths 52 and 104, or using any other desired mechanism ormethod. Because swellable plugs 108 are within a dry field formed bybolus 100, they do not begin to swell or to occlude.

[0044]FIG. 10C shows that sheath 52, along with swellable plugs 108, arethen withdrawn proximally. As soon as sheath 52 and plugs 108 arewithdrawn proximally to a point outside of vessel 10, the gas bolus 100escapes from vessel 10. This produces a visual and audio feedbackindicating that sheath 52 and plugs 108 have just cleared vessel 10.Sheath 52 is then withdrawn further proximally. Once the gas bolus 100has vented, blood from within vessel 10 engages and wets swellable plugs108. Sheaths 52 and 104 and delivery member (or wire) 106, are thenwithdrawn proximally as shown by FIG. 10B, leaving plugs 108 in place inthe desired position.

[0045] Although the present invention has been described with referenceto preferred embodiments, workers skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention.

What is claimed is:
 1. A closure device for closing an opening in a bodycavity, comprising: a closure member having an external, tissue engagingsurface formed with fibrous tissue engaging surface irregularities; andan elongate member disconnectably connected to the closure member. 2.The closure device of claim 1 wherein the surface irregularities are ina non-grasping orientation relative to movement of the closure member ina first direction.
 3. The closure device of claim 2 wherein the surfaceirregularities are in a grasping orientation relative to movement of theclosure member in a second direction, opposite the first direction. 4.The closure device of claim 3 wherein the surface irregularities are ona distal portion of the closure member.
 5. The closure device of claim 4wherein the elongate member is disconnectably connected to a proximalportion of the closure member.
 6. The closure device of claim 5 whereinthe elongate member is frictionally connected to the closure member. 7.The closure device of claim 5 wherein the elongate member is connectedto the closure member with a frangible mechanical connection.
 8. Theclosure device of claim 1 wherein the elongate member includes a hollowdistal end sized to receive a portion of the closure member therein. 9.The closure device of claim 1 wherein the elongate member comprises acatheter.
 10. The closure device of claim 1 wherein the elongate membercomprises a wire.
 11. The closure device of claim 3 wherein the surfaceirregularities comprise proximally facing hook portions.
 12. The closuredevice of claim 11 wherein the hook portions comprise ridges extendingabout the surface of the closure member.
 13. The closure device of claim1 wherein the closure member comprises a substantially rigid materialduring delivery.
 14. The closure device of claim 13 wherein the closuremember comprises a swellable material.
 15. The closure device of claim14 wherein the swellable material is coated with a soluble coating thatimparts rigidity prior to dissolution.
 16. The closure device of claim14 wherein the swellable material comprises collagen.
 17. The closuredevice of claim 1 wherein the opening has fibrous tissue locatedproximally thereof and wherein the surface irregularities engage andbecome entangled in the fibrous tissue as the collapsible member ismoved proximally relative thereto.
 18. The closure device of claim 17wherein the opening is defined by relatively smooth tissue and whereinthe surface irregularities pass the relatively smooth tissue withoutbecoming entangled therein when the closure member is moved proximalrelative thereto.
 19. A method for closing an opening in a body cavityhaving fluid therein, comprising: establishing a dry field in the bodycavity adjacent the opening; inserting a liquid swellable material intothe dry field; withdrawing the liquid swellable material from the bodycavity through the opening until the liquid swellable material engagefibrous tissue proximal of the opening; and implanting the liquidswellable material outside the body cavity to close the opening.
 20. Amethod of claim 19 and further comprising: removing the dry field fromthe body cavity so liquid from the body cavity contacts and swells theswellable material.
 21. A method of claim 20 wherein establishing a dryfield comprises: introducing an inert gas into the body cavity toestablish a bolus of the gas adjacent the opening.
 22. The method ofclaim 21 wherein introducing an inert gas comprises: introducing asheath into the body cavity through the opening; and introducing the gasthrough the sheath.
 23. The method of claim 22 wherein inserting aswellable material comprises: inserting the swellable material with anelongate member through the sheath.
 24. The method of claim 23 whereinremoving the dry field comprises: withdrawing the liquid swellablematerial and the sheath from the opening such that the gas vents fromthe body cavity through the opening.
 25. A method of closing an openingin a body cavity, comprising: advancing fibrous tissue engaging membersdistally through the opening into the body cavity; withdrawing thefibrous tissue engaging members proximally through the opening to anengagement region where the fibrous tissue engaging members engagefibrous tissue proximal of the opening; and placing a closure member atthe engagement region.
 26. The method of claim 25 wherein placing theclosure member comprises: advancing a swellable material to theengagement region; and releasing the swellable material.
 27. The methodof claim 25 wherein the fibrous tissue engaging members are connected toan elongate member and wherein advancing the swellable materialcomprises: advancing the swellable material over the elongate member tothe engagement region.
 28. The method of claim 27 wherein the swellablematerial comprises a plurality of disc shaped pieces having an aperturetherein and wherein advancing the swellable material over the elongatemember comprises: advancing the swellable material over the elongatemember such that the aperture receives the elongate member.
 29. Themethod of claim 27 wherein the swellable material comprises a sheet ofswellable material and wherein advancing the swellable material over theelongate member comprises: folding the sheet to form a generallycylindrical member having an aperture defined therethrough; advancingthe folded sheet over the elongate member such that the aperturereceives the elongate member.
 30. The method of claim 27 wherein thefibrous tissue engaging members comprise hooks, and further comprising:prior to advancing the swellable material, moving the hooks toward oneanother to reduce a size of the opening.
 31. The method of claim 30wherein the hooks are supported in a spread configuration by acollapsible member and wherein moving the hooks comprises: sliding aclosing sheath over the collapsible member to collapse the collapsiblemember.
 32. The method of claim 31 and further comprising: afteradvancing the swellable material, advancing the closure sheath distallyto receive the hooks therein; and withdrawing the hooks in the closuresheath proximally.
 33. A closure apparatus for closing an opening in abody cavity, comprising: a plurality of fibrous tissue engaging memberscoupled to a proximally extending elongate member, the fibrous tissueengaging members being movable between an expanded position and acollapsed position; a closure sheath sized to receive the elongatemember and slidable thereover to move the fibrous tissue engagingmembers from the expanded position to the collapsed position; a deliverysheath sized to receive the closure sheath and having a distal end sizedto engage the fibrous tissue engaging members when in the expandedposition; and a closure member having an aperture defined therein sizedto receive the closure sheath.
 34. The closure apparatus of claim 33wherein the closure member comprises: a generally disc shaped memberhaving the aperture defined therein.
 35. The closure apparatus of claim34 wherein the generally disc shaped member comprises: a plurality ofdisc shaped pieces each having an aperture defined therein and beingarranged in a generally coaxial orientation.
 36. The closure apparatusof claim 33 wherein the closure member comprises: a sheet of pliable,swellable material folded into a generally tubular shape having theaperture defined therethrough.
 37. The closure apparatus of claim 33wherein the closure member comprises: a plurality of sheets of pliable,swellable material, each folded into a generally tubular shape havingthe aperture defined therethrough.
 38. The closure apparatus of claim 37wherein the plurality of sheets are disposed over the closure sheath ina generally coaxial arrangement.
 39. The closure apparatus of claim 33wherein the fibrous tissue engaging members comprise: a plurality ofhook-shaped members.
 40. The closure apparatus of claim 39 wherein theplurality of hook-shaped members are oriented to be proximally facinghook-shaped members.
 41. The closure apparatus of claim 40 wherein theproximally facing hook-shaped members are sufficiently resilient todeform to be received within the closure sheath upon distal advancementof the closure sheath distally beyond the proximally facing hook-shapedmembers.